Tobacco & Nicotine Harm Reduction
Tobacco and Nicotine Harm (THR) Reduction Solutions
We operate a 100-bed clinical unit located in the Kansas City Metropolitan area and have a team of experienced professionals that have conducted a large number of tobacco and nicotine studies with numerous types of products.
Smoking Rooms
Housed within our facility are seven indoor exposure rooms, including two large and five individual rooms. Each are equipped with advanced air handling and ventilation/filtration to allow us to conduct these unique types of studies at our site.
- Enables PK/ Abuse Liability data collection while volunteers use study products
- Dedicated ad libitum and controlled–use environment
- Allows direct observation of product use behavior
- Facility design allows different group sizes
- Accomodates different product types
Enables PK/Abuse Liability data collection while volunteers use study products
Dedicated ad libitum and controlled–use environment
Allows direct observation of product use behavior
Facility design allows different group sizes
Accomodates different product types
Pharmacy
Our 2,500 sq. ft. pharmacy contains a dedicated area for the preparation of the harm reduction products and has the necessary equipment to weigh products both pre and post product administration. Our pharmacists have signficant experience in the handling of tobacco and nicotine products.
Bioanalytical Laboratory
PK and biomarker samples are analyzed in a bioanalytical laboratory with deep experience in this field. Services include the application of bioanalytical methods for biomarker analysis, the development of new bioanalytical methods, and method validation in accordance with FDA guidelines. Our preferred partner also provides biomarker analysis for tobacco harm reduction, chemical risk assessment, metabolomics and metabolite identification.
Multi-Site Capabilities
Our external site network has a proven track record of undertaking nicotine and tobacco harm reduction studies. This model provides a strategic advantage for larger, multi-site trials. We have a robust feasibility and qualification process to ensure that only the most qualified sites are participating in your study to ensure recruitment milestones and study deliverables are met on time.
Regulatory Consulting
We offer end-to-end scientific and regulatory support for tobacco and nicotine products through a collaborative network of experienced specialty partners. By integrating clinical research, regulatory strategy, and scientific justification, we assist our clients in developing robust evidence to support PMTA and related submissions. Our team works beside your organization from product development and manufacturing to clinical evidence and final submission, ensuring your THR product is supported by a clear regulatory pathway. We leverage our expertise in pharmaceutical research and apply the same quality and oversight standards to tobacco and nicotine projects.
Contact Us
Learn how we can support your upcoming trial
Contact Us
Learn how we can support your upcoming study
Tobacco and Nicotine Clinical Study Experience
DVCR has significant expertise in the conduct of a wide range of tobacco and nicotine clinical studies such as:
Abuse Liability (AL)
Predicts the likelihood that the use of the tobacco product would result in addiction and be used repeatedly or sporadically resulting in undesirable effects. Abuse liability evaluations should consider both the addictiveness and abuse/misuse potential of the new product as well as exposure to nicotine during product use (6).
Biomarkers of Exposure (BoE)
The use of tobacco products results in the uptake of nicotine and a wide range of other chemicals. These chemicals and their metabolites, measured in bodily fluids and tissues, constitute biomarkers of exposure.
Biomarkers of Potential Harm (BoPH)
Measures short-term health effects such as inflammation and oxidative stress.
Topography
How individual users consume the product, i.e., the number of puffs, puff duration, puff intensity, duration of use, etc.
Bioequivalence (BE)
Comparing two different products to demonstrate they are equivalent.
Other PK/PD studies
PK: What the body does to investigational product
PD: What the investigational product does to the body
Abuse Liability (AL)
Predicts the likelihood that the use of the tobacco product would result in addiction and be used repeatedly or sporadically resulting in undesirable effects. Abuse liability evaluations should consider both the addictiveness and abuse/misuse potential of the new product as well as exposure to nicotine during product use (6).
Topography
How individual users consume the product, i.e., the number of puffs, puff duration, puff intensity, duration of use, etc.
Biomarkers of Exposure (BoE)
The use of tobacco products results in the uptake of nicotine and a wide range of other chemicals. These chemicals and their metabolites, measured in bodily fluids and tissues, constitute biomarkers of exposure.
Bioequivalence (BE)
Comparing two different products to demonstrate they are equivalent.
Biomarkers of Potential Harm (BoPH)
Measures short-term health effects such as inflammation and oxidative stress.
Other PK/PD studies
PK: What the body does to investigational product
PD: What the investigational product does to the body
We provide medical writing services for tobacco/nicotine clinical studies including:
Full study design, synopsis and protocol development
Clinical Study Report (CSR) Writing
Development of Statistical Analysis Plans (SAPs), source documents and database requirements
Tobacco Harm Reduction Experts
TC DeLuca
Bio
TC DeLuca, Director of THR Operations, brings over 25 years of clinical research experience to DVCR. Prior to joining DVCR, she was head of clinical operations for a large tobacco company where she developed a strong knowledge base of tobacco harm reduction and study design. TC also has extensive experience in pulmonology trials and site management.
Neil Sherwood, PhD
Bio
Neil Sherwood has a degree in Experimental Psychology from the University of Oxford and a Ph.D. in Psychopharmacology from the University of Leeds. After a period in academic research, he joined Novartis Pharma AG as a clinical pharmacologist, and then Japan Tobacco International in 2001where he oversaw clinical and behavioural research programs. Since 2016 he has acted as a consultant on scientific and regulatory issues. In addition to publishing several studies and reviews, he has been an active member of the CORESTA organisation and currently serves on the Tobacco Harm Reduction committee.
Collin Gerringer
Bio
Collin Gerringer is the Manager of THR Operations and a Senior Study Manager at DVCR, where he oversees clinical research study site operations from startup through closeout and supports THR client operations. He has over 12 years of clinical research experience in rare diseases, human abuse potential studies, and tobacco and nicotine harm reduction.
Ajesh Raju
Bio
Ajesh Raju, Senior Project Manager, has worked in the biopharmaceutical and medical device industry for over 15 years. He brings extensive experience leading cross functional teams, managing complex timelines, and delivering studies from start up through close out. His background includes hands on project management of tobacco harm reduction studies, with a strong focus on THR operations, study planning, vendor coordination, and day to day execution. Ajesh is skilled in stakeholder management, risk assessment, and practical problem solving, and is responsible for overseeing all project management activities to ensure studies are delivered efficiently and in line with regulatory and scientific expectations.
Tobacco & Nicotine Harm Reduction Brochure
Learn how Dr. Vince Clinical Research supports tobacco and nicotine trials
Scientific and Operational Execution of Tobacco Harm Reduction Studies
This session will present key considerations for successful planning of THR activities
Assessing the Abuse Liability of Tobacco and Nicotine Products
Discover key regulatory requirements, evaluation methodologies and the latest research on addictiveness and potential harm.
Tobacco & Nicotine Harm Reduction Brochure
Learn how Dr. Vince Clinical Research supports tobacco and nicotine trials
Scientific and Operational Execution of Tobacco Harm Reduction Studies
This session will present key considerations for successful planning of THR activities
Assessing the Abuse Liability of Tobacco and Nicotine Products
Discover key regulatory requirements, evaluation methodologies and the latest research on addictiveness and potential harm.
Requirements for New Tobacco and Nicotine Products
In 2017, the FDA set forth an initiative to significantly reduce tobacco-related disease and death, placing nicotine and the issue of addiction at the center of the Agency’s tobacco regulation efforts. This initiative encouraged the development of innovative tobacco products that may be less dangerous than cigarettes. Furthermore, a key element of the FDA’s approach is in increasing awareness that nicotine, while still highly addictive, is most harmful when delivered through smoke particles in combustible cigarettes (1).
To that end, in order to introduce a new tobacco or nicotine product into the marketplace, companies must receive an authorization from the FDA after submitting an application. Applications are thoroughly evaluated in order to determine whether the new products meet relevant standards.
There are currently three pathways to market new tobacco products (2):
Premarket Tobacco Product Applications (PMTA)
Premarket Tobacco Product Applications (PMTA): Must prove that the new product would be “appropriate for the protection of the public health.” The FDA’s Final Rule for Premarket Tobacco Product Applications and Recordkeeping Requirements states, “The rule requires an applicant to submit detailed information regarding the physical aspects of its new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product and whether it presents the same or different risks compared to other tobacco products (3).”
When reviewing PMTAs, the FDA considers the following items (4):
- Risks and benefits to the population, including people who would be likely to use the new product as well as nonusers
- The likelihood that current users of tobacco products would stop using them if the proposed product becomes available
- Whether nonusers would become more or less likely to begin using tobacco products if the proposed product becomes available
To read the full FDA guidance document for Premarket Tobacco Product Applications, click here.
Substantial Equivalence (SE)
In this pathway, a new product is determined to be “substantially equivalent” to a product that is already available in the market by proving it has the same characteristics as that predicate product. Alternately, if the product has different characteristics, it must demonstrate that it does not raise different public health questions as does the existing product.
Request Exemption from Demonstrating Substantial Equivalence (EX REQ)
This pathway is for products that have been modified by adding or removing an additive or by increasing/decreasing the quantity of an existing tobacco additive within a product.
For sponsors who seek to market a tobacco product with reduced risk, they must submit an MRTP application.
Modified Risk Tobacco Product (MRTP)
Following PMTA authorization, for the FDA to issue an exposure modification order, the application must demonstrate a substantial reduction of harmful substances within the product and that there is an actual reduction in the exposure of that substance to consumers. Furthermore, the product must not expose consumers to higher levels of other harmful substances compared with currently available products. As stated in the FDA’s draft guidance document, the “issuance of the exposure modification order is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products (5).”
To read the full FDA guidance document for Modified Risk Tobacco Product Applications click here.
References
1 FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death. (2017, July 28). FDA News Release. U.S. Food and Drug Administration. Retrieved June 26, 2023, from https://www.fda.gov/tobacco-products/ctp-newsroom/fdas-comprehensive-plan-tobacco-and-nicotine-regulation
2 Products, C. for T. (2022, April 11). Market and distribute a tobacco product. U.S. Food and Drug Administration. https://www.fda.gov/tobacco-products/products-guidance-regulations/market-and-distribute-tobacco-product
3 Premarket Tobacco Product Applications and Recordkeeping Requirements, 21 C.F.R. § 1100, 1107, 1114 (2021). https://www.federalregister.gov/documents/2021/10/05/2021-21011/premarket-tobacco-product-applications-and-recordkeeping-requirements
4 Products, C. for T. (2023, April 11). Premarket tobacco product applications. U.S. Food and Drug Administration. https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications
5 Products, C. for T. (2020, February 13). Modified risk tobacco product applications. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modified-risk-tobacco-product-applications
6 U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products. (2023, March). Premarket tobacco product applications for electronic nicotine delivery … https://www.fda.gov/media/127853/download
